Presentation (CTI)

OBJECTIVES: To evaluate the gap between initial regulatory evidence and health technology assessment (HTA) requirements for high-risk medical devices undergoing early benefit assessments (§137h SGB V) in Germany.
METHODS: A systematic review of all §137h SGB V assessment decisions published online by the Federal Joint Committee (G-BA) and IQWiG between January 2020 and May 2026 was conducted. Data was extracted on feedback given to clinical study designs, comparator choices, and the methodological justifications for the final reimbursement decisions.
RESULTS: A total of 21 published medical device methods were identified. Six (29%) were excluded from a full benefit assessment for failing statutory prerequisites. Three methods currently await a final decision. Of the 12 methods completing full HTA evaluation, none demonstrated a proven added benefit; all 12 (100%) received a verdict of "neither benefit nor harm proven." Three failure patterns emerged consistently: studies lacked a comparator group; trial patients did not reflect the population defined in the assessment; and submitted evidence was based on earlier versions of the device that had since been technically updated, with no new studies conducted on the modified technology.
CONCLUSIONS: Across six years of §137h assessments, no high-risk medical device achieved proven added benefit. The consistent failure does not reflect device safety concerns but rather a mismatch between the evidence generated by manufacturers and HTA requirements. Achieving added benefit requires prospective comparative RCTs against the active standard of care, evaluated in precisely defined patient subpopulations using patient-relevant endpoints. These findings have direct implications for manufacturers seeking reimbursement access in Germany and suggest that earlier regulatory-HTA alignment could substantially improve assessment outcomes.